The new indication for brexpiprazole will make it the first FDA-approved treatment for Alzheimer’s. The atypical antipsychotic was previously approved for treating major depressive disorder and schizophrenia, reports MedPage Today’s recent article entitled, “FDA OKs First Drug for Agitation in Alzheimer's Dementia Therapies.”
"Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer's disease. 'Agitation' can include symptoms ranging from pacing or restlessness to verbal and physical aggression," said Tiffany Farchione, MD, director of the division of psychiatry in the FDA's Center for Drug Evaluation and Research, in a press release.
"These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression."
In April, an advisory committee voted 9-1 in favor of the expanded indication. Advisors noted that the data presented at the meeting were sufficient to identify a population in whom the benefits of treatment outweighed its risks.
Committee members largely agreed that this indication would benefit elderly patients. However, they expressed concerns over the relatively limited safety data for the treatment.
Researchers found that treatment achieved a statistically significant reduction in agitation over a 12-week treatment period, based on the Cohen Mansfield Agitation Inventory (CMAI). Patients on a 2-mg or 3-mg daily dose of brexpiprazole had improved CMAI scores versus placebo.
The trials also showed that the drug had a similar safety profile compared with the treatment's use in adults with schizophrenia and major depressive disorder.
Brexpiprazole's label will continue to carry a boxed warning about the risk of increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs.
The warning further states that the drug isn’t approved for patients with dementia-related psychosis who aren’t experiencing agitation associated with Alzheimer's.
The most common side effects of brexpiprazole among patients with agitation associated with dementia due to Alzheimer's include headache, dizziness, urinary tract infections, nasopharyngitis and trouble with sleep.
Reference: MedPage Today (May 11, 2023) “FDA OKs First Drug for Agitation in Alzheimer's Dementia Therapies